Polymer implants offer hope

EDMOND, Okla. (Ivanhoe Newswire) – As the baby boomer generation gets older, more than 40-million Americans are at risk for osteoporosis and vertebrae compression fractures. A new procedure offers hope.

Today, walking his dog is one of John Wallace’s morning pleasures. But not long ago, this was just wishful thinking. Wallace suffered from a compression fracture caused by weakened bones.

“My spine had settled down on the nerve mass there and it was hurting all over my legs,” Wallace told Ivanhoe.

“A compression fracture is like it would sound—it’s like stepping on the top of a coke can and scrunch it down,” Dr. Beall told Ivanhoe.

The procedure used on Wallace was the first new method of treating these fractures in the last decade. The incision is a small poke-hole.

“It goes in through a needle and then the device goes in a little loop of wire in and over that wire goes artificial bone to provide a cast and in that we inject medical cement. It takes about twenty to thirty minutes to perform and the patients get immediate pain relief,” Dr. Beall explains.

And for patients like Wallace—pain-free means more time with man’s best friend.

”I would certainly be able to do anything that any other man that’s approaching 88 would, would dare to do,” Wallace said.

Dr. Beall says that the surgery costs a fraction of the price of traditional surgery and gives the patients a better chance at avoiding deadly symptoms caused by inactivity—like pneumonia.

BACKGROUND: According to Dr. Douglas Beall, over 200 million people worldwide suffer from osteoporosis, which is the medical term for compression fractures. If you don't know what these are, the sound can be compared to the sound of stepping on the top of a can as it scrunches down. The patient has acute and severe intense pain. Dr. Beall says, “50% of women and 25% of men will sustain an osteoporotic fracture in their lifetime.” The patients are usually elderly or people who have osteoporosis or soft bones. All or part of the spine bone collapses. In most cases, people are unaware of how or when they fractured the bone. If untreated, compression fractures can lead to curvature of the spine. This can impair balance and overall activity levels.

TREATMENTS: Treatments can be nonsurgical management. For example, the patients are told to get rest, bracing and let time heal the wound. But in some cases, nonsurgical management can lead to a high rate of morbid injury. That's because they lay in bed, get pneumonia and blood clots to the lungs. Some doctors say patients should wait no longer than eight weeks to seek treatment. Another standard procedure is the balloon kyphoplasty. This inserts a balloon in the spine at the point of the fracture, which is inflated to restore the spine height. The balloon is then replaced by cement so there is not another collapse. (Source: http://sciencebusiness.technewslit.com/?p=16654)

NEW TECHNOLOGY: Patients now can be treated with vertebrae augmentation. Doctors make an incision the size of a small poke-hole. They use an artificial bone (PEEK or Polyetheretherketone) along with medical cement. It takes about 20 to 30 minutes to perform the procedure and there's immediate pain relief. It costs a fraction of the price of a traditional surgery. The new treatment is approved only for the lower thoracic and lumbar vertebrae and is the first new technology to be approved in the United States in a decade, according to Dr. Beall. Complications could include leakage of the cement and fracture of adjacent bones, according to Dr. Mark Raden with the Staten Island University Hospital in New York City. (Source: http://consumer.healthday.com/bone-and-joint-information-4/osteoporosis-news-514/new-repair-option-for-compression-fractures-685977.html)

Dr. Beall: Yes indeed. There are about seven hundred thousand fractures in the United States a year. There are about five hundred and fifty thousand vertebral compression fractures. These fractures are usually characterized by acute and severe intense pain. It happens generally in the elderly population or in people that have osteoporosis or soft bones. Each one of these fractures are associated with a rate of mortality meaning death from the fracture. Typically people die from immobility from the fracture of about 8 to 9 times age matched controls. Which means they’re not double or triple or quadruple times increased risk of dying than somebody else their same age. It’s between eight and nine times.

Explain the procedure.

Dr Beall: The procedure itself goes in a compression fracture. The compression is a crush fracture, it’s like stepping on the top of a coke can to scrunch it down. The vertebrae gets scrunched from top to bottom. It doesn’t break like a stick. It crushes from top to bottom. What this does is it accesses the vertebrae through a small poke hole. No incision, no sutures, no staples just a small little poke hole. It goes in through a needle and then the device goes in and puts a small nitinol wire. It’s nickel titanium. It’s got a memory to it. So a little loop of wire in and then over that wire goes artificial bone to provide a cast of support, a strut within the vertebral body itself than in that we inject medical cement to secure everything in place, everything comes out and we’re done.

So you’re talking about a small procedure then?

Dr Beall: Yes. This is not associated with any incision, staples, or sutures. It’s a small poke hole we just put a Band-Aid over it. People come in, one little poke hole per fracture and it takes about 30 - 40 minutes to perform and the patients get immediate pain relief. The average patient, a typical conventional patient, will come in and the average amount of pain somebody has with one of these fractures is intense. Out of 10 it’s an eight. It’s a nine, ten, some patients are twelve and immediately afterwards patients get pain relief. They average typical patient goes from an eight out of ten fracture to a two or one. Sometimes people go to a zero and have no pain after the procedure.

If you didn’t have this procedure what were your alternatives?

Dr Beall: The alternatives are really nonsurgical management. We had patients who have nonsurgical management. They get rest, bracing, analgesics time, take some time and then we see if it heals or not. Most of the patients who come in, we divide them into two categories; ones that have low-grade pain to kind of medium pain and ones that have moderate to severe or severe pain. Patients who have low-grade pain, not very much pain, they’ll do okay mostly. If they can tolerate nonsurgical management we use that. But the vast majority of patients, the patients that I see, will come in with moderate to severe pain, they don’t do well. Even with nonsurgical management they tend not to do well and they tend to have a high rate of morbid injury. They lay in bed, they get pneumonia, they get blood clots to the lungs, they die prematurely from those two things. If patients die they don’t die from a fracture, they die of immobility, they die of complications and problems with immobility, pneumonia and blood clots to the lungs, pulmonary embolism. To try to prevent the immobility typically in patients with moderate to severe or severe pain we’ll go ahead and offer them vertebral augmentation which means putting the device in, artificial bone, gluing it in with medical cement, medical bone cement and the patients are better immediately. They can tell when you roll them off the table after the procedure is finished. We do this under constant sedation which is IV sedation. We don’t do general anesthesia and put a tube down their throat to breathe. It’s just IV conscious state is a very comfortable minimally invasive procedure. Whenever we roll them off the table immediately it’s a stark contrast from whenever we roll them on to the table. It’s an outcry you know it’s a severe and intense pain and any time you move them you’re moving that fracture and it causes severe and intense pain. So when we move them onto the table a typical responses is an outcry, you know of intense pain, and when they move them off the table there is no response.

Why would somebody choose to have big surgery for the same condition? Is that the only option, your offering something new and innovative but has it traditionally been the only other option?

Dr. Beall: If a young person has a high velocity injury or if they have problems they can’t move their legs, have neurological bowel or bladder control loss of those things, if they have neurological deficits, problems with the nerve, crushing of their spinal cord, they are not a candidate for this. But the vast, vast majority of these are candidates for this. There is really no reason to have an open procedure, typically these were treated with a big open procedure, screws, rods and big constructs and big incisions. No reason to do that anymore. These patients are very, very well fixed this way. The whole reason we don’t use screws and rods in patients that have soft bones is the same reason you don’t hang a heavy picture on drywall, it pulls right out. So what we do is the same as securing it on the inside. This is supporting the inside before you hang that heavy picture. This is supporting the inside making an internal cast inside the bone, gluing the fracture back together and making it secure so patients can put weight on it and that’s what they feel, that’s the pain relief that they feel. We re-expand the vertebral body using an internal cast of bone, the artificial bone and then we secure it in place. We secure and stabilize the cracks in the vertebrae with the medical cement. Patients are better immediately because they have structural support.

Is this your procedure, did you invent this procedure or is it a continuing of the study?

Dr Beall: It’s an amalgam, there’s lots of people that have input in this. I was one of the investigators in the Cass trial. This device is called Kiva.

What is the cost?

Dr Beall: Comparing it to open surgery it’s a fraction of the price.

Is there anything else you think we haven’t covered that you think is really important to add?

Dr Beall: The important part of this is just the scope and scale of the problem. If you were to say one thing about vertebral compression fractures and the treatment of that and recognition of it is that they are under recognized and undertreated. This is one of the most common problems we have. It’s one of the most common problems we have that is associated with a high rate of mortality, a high rate of morbid injury and is completely treatable. Not only is it completely treatable, it’s easily treatable. The recognition of the problem leading to the appropriate treatment is the primary problem. This treatment has only been commercially available for about seven weeks now. This is brand-new. Balloon kyphoplasty has only been available since about, in a significant degree, 1999-2000 but people still don’t know about it and it’s heartbreaking to see people, on the average patient that I see for this particular problem, have had their fracture for about 4 to 6 months. Keeping in mind that moderate to severe painful fractures don’t heal and people die at a very high rate. This is one of the things along with hip fractures we can demonstrate lifesaving in terms of treating patients. A recent article showed an increase in life expectancy, an increase in life of 2.2 to 7.3 years more with patients who are treated with this versus patients who were treated with nonsurgical management. This is literally a lifesaving procedure. It prevents injury too, morbid injury, if patients die they die of pulmonary embolism, blood clots to the lungs, and pneumonia. And this will get patients up immediately it will prevent the debilitation from immobility and in terms of scope and scale I mentioned the seven hundred thousand fractures a year roughly five hundred to five hundred fifty of these will be vertebral compression fractures. This is the tip of the iceberg because our first baby boomers turn 65 in 2011 and if you were to go back 10 years and forward 20 years, the over 65 patient population will double. It’s a huge issue. Vertebral fractures affect people who have soft bones or osteoporosis and people who have soft bones or osteoporosis will grow enormously over the next 20 years. It’s one of the most common problems that has one of the best solutions. I do lots of things with the spine. I bet I do 100 different things with the spine if you were to parse everything out. This is the single best thing that I do in terms of patient outcome and satisfaction. Out of all the things that I do in the spine this has the best outcomes in terms of patient satisfaction and efficacy, the ability to really get rid of pain and reestablish a patient’s life and everybody does this, just like what you’re doing now. Everybody nods their head in agreement and I’ve not had any word of disagreement the whole time. This really is fantastic. In patients I would say the biggest mistake is a mistake of error of omission, of not recognizing it, not treating it. This is a very, very effective treatment for a large number of patients that is very easy on them, highly minimally invasive and there are no restrictions afterwards. It’s one of those things that you can get back, gain control of your life again. You can get up you get out and do so without debilitating life-changing severe back pain. And I’m happy to put no restrictions on these patients, they get out and typically do fantastic.